Name/CompanyApproval Dates and Comments

Collagen-based dermal filler

Ortho Dermatologics

The US FDA approved a labeling supplement in June 2009 that includes efficacy and safety data through 12 months, for this collagen-based dermal filler for the correction of moderate to deep facial wrinkles and folds, e.g., nasolabial folds.

Injectable Poly-L-lactic acid
Sculptra Aesthetic®
sanofi-aventis US

The US FDA approved this facial injectable in July 2009 for the correction of shallow to deep nasolabial fold (smile lines) countour deficiencies and other facial wrinkles that are treated with the appropriate injection technique in healthy patients.

Ibritumomab tiuxetan

Spectrum Pharmaceuticals

The US FDA approved an expanded label for this product in August 2009 for the treatment of patients with previously untreated follicular non-Hodgkin’s lymphoma who achieve a partial or complete response to first-line chemotherapy.

Drug News

In August 2009, the US FDA reported that it is requiring stronger warnings in the prescribing information for a class of drugs known as TNF blockers. The warnings, which included an updated boxed warning, highlight the increased risk of cancer in children and adolescents who receive these drugs to treat juvenile rheumatoid arthritis, the inflammatory bowel disorder, Crohn’s disease, and other inflammatory diseases. The FDA is working with the manufacturers to explore new ways to further define the risk of cancer in children and adolescents who use these drugs.

Based on a safety evaluation of botulinum toxin (Btx) products, the US FDA concluded that the prescribing information for OnabotulinumtoxinA (marketed as Botox®/Botox Cosmetic®) and RimabotulinumtoxinB (marketed as Myobloc®) must be updated to ensure their continued safe use. On July 31, 2009, the FDA approved the following revisions to the prescribing information of Botox®/Botox Cosmetic® and Myobloc®:

  • A Boxed Warning highlighting the possibility of potentially life-threatening distant spread of toxin effect from the injection site after local injection.
  • A Risk Evaluation and Mitigation Strategy (REMS) that includes a medication to help patients understand the risks and benefits of Btx products.
  • Changes to the established drug names to reinforce individual potencies and prevent medication errors. The potency units are specific to each botulinum toxin product, and the doses or units of biological activity cannot be compared or converted from one product to any other Btx product. The new established names reinforce these differences and the lack of interchangeability among products.

The other Btx product in this class, abobotulinumtoxinA (marketed as Dysport®), was approved in April 2009 and included the Boxed Warning, REMS, and new established name at the time of approval. The FDA urges healthcare professionals and patients to report side-effects from the use of these products to the FDA’s MedWatch Adverse Event Reporting program.